FDA Adverse Event
Injury
Summary report: N
COMPACT LOW IMPEDANCE LEAD
MDR report key: 1001560
·
Received February 21, 2008
Report
- Report Number
- 6000153-2008-00838
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- August 25, 2006
- Report Date
- January 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PATIENT REPORTED THAT HER LEGS FELT PARALYZED WHEN SHE INCREASED THE STIMULATION TO COVER HER BACK PAIN. AN X-RAY WAS DONE IN 2006 WHICH REVEALED THAT THE LEADS WERE POSITIONS IN THE EPIDURAL SPACE AT THE MID-INFERIOR ASPECT OF T9. THE PATIENT HAS NOT BEEN SEEN BY THE HCP SINCE THIS TIME. THE PATIENT OUTCOME IS UNK. REFERENCE MFR REPORT #6000153200800837.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPACT LOW IMPEDANCE LEAD | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3778 | V007983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | EXTENSION MODEL EXTENSION LOT# UNK| UNK CONVERSION TYPE MODEL LEAD LOT# UNK| IMPLANTABLE NEURO STIMULATOR MODEL 37711| LOT# NJH710836H IMPLANTED| EXPLANTED| EXPLANTED| EXPLANTED |